![Sample our Medicine, Dentistry, Nursing & Allied Health journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5944/TOC-Subject-Sample-2021-Medicine-Dentistry-Nursing-Allied-Health.jpg"})
ABSTRACT
The safety of 9-valent HPV vaccine (9vHPV) has been established with regard to common and uncommon adverse events. However, investigation of rare and severe adverse events requires extended study periods to capture rare outcomes. This observational cohort study investigated the occurrence of three rare and serious adverse events following 9-valent human papillomavirus (9vHPV) vaccination compared to other vaccinations, in US individuals 9–26 years old, using electronic health record data from the Vaccine Safety Datalink (VSD). We searched for occurrences of Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and stroke following 9vHPV vaccination from October 4, 2015, through January 2, 2021. We compared the risks of GBS, CIDP, and stroke following 9vHPV vaccination to risks of those outcomes following comparator vaccines commonly given to this age group (Td, Tdap, MenACWY, hepatitis A, and varicella vaccines) from January 1, 2007, through January 2, 2021. We observed 1.2 cases of stroke, 0.3 cases of GBS, and 0.1 cases of CIDP per 100,000 doses of 9vHPV vaccine. After observing more than 1.8 million doses of 9vHPV, we identified no statistically significant increase in risks associated with 9vHPV vaccination for any of these adverse events, either combined or stratified by age (9–17 years of age vs. 18–26 years of age) and sex (males vs. females). Our findings provide additional evidence supporting 9vHPV vaccine safety, over longer time frames and for more serious and rare adverse events.
Abbreviations
| CDC | = | US Centers for Disease Control and Prevention. |
| CIDP | = | Chronic inflammatory demyelinating polyneuropathy. |
| GBS | = | Guillain-Barré syndrome. |
| HPV | = | Human papillomavirus. |
| 4vHPV | = | 4-valent human papillomavirus vaccine. |
| 9vHPV | = | 9-valent human papillomavirus vaccine. |
| ICD | = | International Classification of Diseases. |
| MenACWY | = | Quadrivalent conjugate meningococcal vaccine. |
| SARS-CoV-2 | = | Severe acute respiratory syndrome coronavirus 2. |
| Td | = | Tetanus-diphtheria vaccine. |
| Tdap | = | Tetanus, diphtheria, and acellular pertussis vaccine. |
| VSD | = | Vaccine Safety Datalink. |
Disclosure statement
MES received support from GSK for a feasibility study unrelated to HPV vaccines. BK received support from Janssen and Novavax for studies unrelated to HPV vaccines. NPK received research support from Merck for a HPV9 safety study and research support from Merck, GlaxoSmithKline, Pfizer, Sanofi Pasture and Protein Science (now Sanofi Pasteur) for unrelated studies. JGD reported receiving support from Janssen Vaccines & Prevention for a study unrelated to HPV vaccines. JCN has received grant funding from Moderna and GSK. She has also received statistical consulting fees from Southern California Permanente Medical Group and Harvard Pilgrim Health Care.
Article summary
Update of previous investigation of 9-valent HPV vaccine safety using a longer study period. No increased risk of rare events associated with 9vHPV identified.
Author contributions statement
Mr. Kieke, Dr. Belongia, and Dr. Donahue conceptualized and designed the original study. Dr. Sundaram drafted the initial manuscript, and reviewed and revised the manuscript including implementing additional analyses and interpreting statistical results. Mr. Weintraub, Ms. Hanson, Dr. Daley, Dr. Hechter, Dr. Klein, Mr. Lewis, Dr. Naleway, and Dr. Nelson provided input on the conceptualization and design of the study, and they, as well as Dr. Donahue, Dr. Belongia, Dr. Sundaram, and Mr. Kieke reviewed and revised the manuscript. Mr. Kieke completed the statistical analyses. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Disclaimer
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Supplementary material
Supplemental data for this article can be accessed on the publisher’s website at https://doi.org/10.1080/21645515.2022.2159215.